| Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
| 510(k) Number |
K870063 |
| Device Name |
CO2 LASER BRONCHOSCOPE SET |
| Applicant |
| Tti Medical |
| 3470 Mt. Diablo Blvd., |
| Suite A150 |
|
Lafayette,
CA
94549
|
|
| Applicant Contact |
ALLEN R HOWES |
| Correspondent |
| Tti Medical |
| 3470 Mt. Diablo Blvd., |
| Suite A150 |
|
Lafayette,
CA
94549
|
|
| Correspondent Contact |
ALLEN R HOWES |
| Regulation Number | 874.4680 |
| Classification Product Code |
|
| Date Received | 01/07/1987 |
| Decision Date | 03/09/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ear Nose & Throat
|
| 510k Review Panel |
Ear Nose & Throat
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|